SPL v4
SPL
SPL Set ID e13fea4e-bd6d-425a-aa7e-1d41dc36bf00
Route
TOPICAL
Published
Effective Date 2025-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (30 g)
Inactive Ingredients
Water Glycerin Glyceryl Stearate Peg-100 Stearate Stearic Acid Polyoxyl 20 Cetostearyl Ether Sodium Hydroxide Lanolin Alcohols Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Phenoxyethanol Triethylene Glycol .alpha.-tocopherol Acetate Edetate Disodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-01

Description

White Petrolatum USP

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

White Petrolatum USP

Uses
  • temporarily protects minor: cuts, scrapes and burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Section 51945-4

Warnings

For external use only.

Do not use on:

  • deep puncture wounds
  • animal bites
  • serious burns.

When using this product, do not get into eyes.

Stop use and ask a doctor if:

•condition worsens

•symptoms last more than 7 days or clear up and occur again within a few days

Directions

apply as needed.

Active Ingredient

White Petrolatum USP

Inactive Ingredients

water, glycerin, glyceryl stearate, PEG—100 stearate, stearic acid, ceteareth-20, sodium hydroxide, lanolin alcohol, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, tocopheryl acetate, disodium EDTA

Keep Out of Reach of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • temporarily protects minor: cuts, scrapes and burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings

For external use only.

Do not use on:

  • deep puncture wounds
  • animal bites
  • serious burns.

When using this product, do not get into eyes.

Stop use and ask a doctor if:

•condition worsens

•symptoms last more than 7 days or clear up and occur again within a few days

Directions

apply as needed.

Active Ingredient

White Petrolatum USP

Inactive Ingredients

water, glycerin, glyceryl stearate, PEG—100 stearate, stearic acid, ceteareth-20, sodium hydroxide, lanolin alcohol, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, tocopheryl acetate, disodium EDTA

Keep Out of Reach of Children (Keep out of reach of Children)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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